FlexBand Eyelet Anchor 91003

GUDID 00850003396255

Hex Eyelet Anchor

Artelon

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00850003396255
• NIH Device Record Key: 5127630d-afb3-4d6f-95c8-7db381af6fbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexBand Eyelet Anchor
• Version Model Number: 91003
• Catalog Number: 91003
• Company DUNS: 066284070
• Company Name: Artelon
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittewr@artelon.com

Device Dimensions

• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 3.85 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003396255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200503

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

[00850003396255]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-01
• Device Publish Date: 2023-05-24

On-Brand Devices [FlexBand Eyelet Anchor]

• 00850003396149: 81001
• 00850003396262: Hex Eyelet Anchor
• 00850003396255: Hex Eyelet Anchor